Buccal Misoprostol Prior to Abdominal Myomectomy for Reduction of Intraoperative Blood Loss: A Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Estimated Intra-operative Blood Loss
研究概览
简要总结
The aim of this research work is to assess the impact of a single preoperative dose of buccal misoprostol in reducing blood loss during abdominal fibroid surgery.
详细描述
This is a trial of women undergoing fibroid surgery at a university-affiliated tertiary care center. Eligible participants will be randomized to receive preoperative 400ucg buccal (under the tongue) misoprostol or placebo on the basis of total fibroid volume, location, parity. Intra-operative blood loss will be compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months
- •Age ≥ 18 years and ≤ 50 years
- •Pre-operative hemoglobin >8 g/dl
- •Willing to have buccal administration of misoprostol or a placebo at least one hour pre-procedure.
- •Ability to understand and the willingness to sign a written informed consent.
- •Admissible medical/surgical history
- •Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills
- •Intraoperative use of vasopressin and uterine tourniquet is permissible
- •Can have had prior Cesarean delivery
排除标准
- •Patients who have had a prior abdominal myomectomy
- •Post-menopausal women
- •Patients with known bleeding/clotting disorders
- •Patients with a history of gynecologic malignancy
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol
- •Any cases converted to abdominal hysterectomy or other additional elective surgical procedures performed at time of abdominal myomectomy will be excluded from data analysis
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Misoprostol
25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.
干预措施: Misoprostol (Drug)
Placebo
25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
干预措施: Placebo (Drug)
结局指标
主要结局
Estimated Intra-operative Blood Loss
时间窗: Intra-operative
Estimate of blood loss occurring during the surgical procedure as determined by anesthesia staff and documented by anesthesia, nursing and surgical staff as per hospital protocol.
次要结局
- Duration of Procedure(Intra-operative)
- Length of Inpatient Hospitalization(Number of days the patient is hospitalized post-operatively, an expected average of 3 days and a maximum of 90 days post-operatively)
- Post-operative Blood Transfusion(From time of surgery completion through discharge from hospital, an expected average period of 3 days)
研究者
Magdy Milad, MD
Professor in Obstetrics and Gynecology, Reproductive Endo & Infertility
Northwestern University